Clinical Trial Manager (CTM) – Respiratory

We are seeking a Clinical Trial Manager (CTM), who will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). The individual will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus will be the oversight of and partnership with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that the quality of data is suitable for regulatory submission/inspections. The CTM will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries.

Key Responsibilities

• Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO and vendors to ensure overall project objectives are met
• Initiate and build strong relationships with key opinion leaders and clinical site staff
• Partner with the CRO(s) to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget
• Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data
• Proactively identify and manage study related risks
• Develop and manage clinical trial documents, including but not limited to protocols, Case Report Forms (CRFs), consent documents, and confidentiality agreements
• Review and manage study related plans and processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring
• Review CRO and vendor contracts/work orders and specifications to align with study objectives
• Review and approve essential document packages to enable timely site activation
• Work closely with Apogee CRA team in the following areas to ensure sites within respective regions are committed to quality and patients’ safety as well as meeting enrolment expectations. Duties include, but are not limited to:   
  • Understand site issues, protocol deviations, noncompliance, and items raised in the monitoring visit reports​
  • 10% review of monitoring and oversight trip reports in their region​
  • Periodic visits to clinical sites within region for relationship building with sites
  • Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Oversee the TMF maintenance and ensure completeness at the end of the study
• Perform periodic QC of the TMF
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices
• Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
• Ensure the study is “inspection ready” always
• Oversee and coach the functional activities of Clinical Trial Associates allocated to the project

Ideal Candidate

• Bachelor’s degree in life science or equivalent
• 5+ years of clinical project management experience in Respiratory therapeutic area with strong preference for COPD/Ashma in conducting international clinical trials in sponsor Pharma/Biotech organization
• Prior phase II and III experience required
• A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
• Experience with budget forecasting and management
• Proven proficiency in overseeing complex studies being managed in house and by a CRO
• Demonstrated ability to lead teams and work in a fast-paced team environment
• Attention to detail and commitment to quality
• Experienced and enjoys building relationships with KOLs and site personnel
• Demonstrated ability to build and deliver on patient enrolment strategies
• Excellent interpersonal and decision-making skills
• Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
• Demonstrated ability to comprehend complex scientific concepts and data
• Proficient in reviewing and assessing clinical data
• Possesses excellent planning, time management & coordination skills
• Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
• Experience in working in a small organization
• Collaborative team-player
• Excellent written and oral communication skills
• Ability to travel globally - Amount will vary upon project needs (up to 25%)

The anticipated salary range for candidates for this role will be $130,000-$145,0000 / year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.